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Completed

NCT Number: NCT00422526

Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Neoplasm Metastasis Neoplasms Neoplastic Processes Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Trimester, Second Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital do Servidor Publico Estadual-FMO, São Paulo, Brazil

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About this study

BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. Asymptomatic women found to have a short cervix (< 15 mm) at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone.

METHODS Cervical length was measured by transvaginal sonography at 22 (range 20-25) weeks in 24,620 pregnant women attending for routine antenatal care. The cervix was 15 mm or less in 413 (1.7%), and 250 (60.5%) of these women participated in a randomized study of vaginal progesterone (200 mg per night) vs identical-looking placebo, between 24 and 34 weeks. Primary outcome was the frequency of spontaneous delivery before 34 weeks (238 days) of pregnancy. Analysis was performed according to the intention-to-treat principle.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (<15 mm).

Exclusion criteria

  • Women with major fetal abnormalities,
  • Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.

Treatment and study plan

Micronised progesterone (Utrogestan)

Drug

Primary outcomes

  1. Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Secondary outcomes

  1. Birth weight, fetal or neonatal death, major adverse outcome before discharge from hospital and need for neonatal special care (admission to special care baby unit, phototherapy, treatment of proven or suspected sepsis, or blood transfusion).

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery

Important dates

Study start
2003
Study completion
2006
First posted
Jan 17, 2007
Registry last updated
Jan 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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